Novo Nordisk Settles $58.7 Million in US Fines

08.09.2017 -

Danish pharmaceutical producer Novo Nordisk’s US subsidiary is paying nearly $58.7 million to resolve claims that, among other things, it misrepresented a warning by the US Food and Drug Administration about the risk that its top-selling diabetes drug Victoza could cause a rare cancer, Medullary Thyroid Carcinoma.

The bulk of the payment, $46.5 million, settles several whistle blower lawsuits instigated by sales representatives but the drugmaker also is forfeiting $12.5 million in profits it made while allegedly marketing the drug under false pretenses between 2010 and 2012, in violation of the federal Food, Drug and Cosmetic Act.

In particular, the US Department of Justice (DoJ) said Novo Nordisk failed to comply with the FDA’s Risk Evaluation and Mitigation Strategy for Victoza, which was approved by the agency with restrictions in 2010. In fact, it instructed its sales representatives to suggest that the warning was ”erroneous, irrelevant or unimportant, thus putting patients at risk.

“When a drug manufacturer fails to share accurate risk information with doctors and patients, it deprives physicians of information vital to medical decision-making,” said acting  assistant US attorney general, Chad Readler.

The settlement also resolves claims brought by 30 US states, alleging that the diabetes specialist disguised sales representatives as medical educators and paid kickbacks to doctors for prescribing its medicines.

Doug Langa, head of Novo’s North American operations, said while the company continues to deny wrongdoing on all of the charges and does not agree with the U.S. government’s conclusions, it is pleased to have negotiated a settlement.

More positively for the drugmaker, the FDA in August declared that Victoza reduces the risk of heart attack, stroke and cardiovascular disease.